Phase II Trial Of Non-Myeloablative Regimen Combining Melphalan, Fludarabine, And Anti-CD52 Monoclonal Antibody (CAMPATH-1H) Followed By An Unmodified Hematopoietic Cell Transplant From An HLA Compatible Related Or Unrelated Donor For Treatment Of Lymphohematopoietic Malignancies
OBJECTIVES:
Overall survival-12 months
Overall survival-24 months
Acute Graft-versus-Host Disease Matched Related patients-up to 4 months post transplant
Acute Graft-versus-Host Disease Unrelated and Mismatched related patients- up to 4 months
post transplant
Chronic Graft-versus-Host Disease Matched Related patients- up to 2 years post transplant
Chronic Graft-versus-host disease Unrelated and Mismatched related patients- up to 2 years
post transplant
- OUTLINE: Patients are stratified according to donor type (HLA-matched related vs
HLA-matched unrelated, single HLA-allele disparate related, or unmatched)
(HLA-mismatched related or matched unrelated donor stratum closed to accrual as of
1/11/06).
Patients receive a nonmyeloablative regimen comprising alemtuzumab IV over 8 hours on days
-8 to -5, fludarabine IV over 30 minutes on days -8 to -4, and melphalan IV over 30 minutes
on days -3 and -2. Allogeneic peripheral blood stem cells or bone marrow is infused on day
0.
Patients receive graft-versus host disease prophylaxis comprising cyclosporine IV every 12
hours beginning on day -1 and continuing orally as tolerated until day 100.
Patients are followed every 6 weeks for 6 months, every 3 months for 6 months, every 3-6
months for 1 year, and then annually thereafter or as clinically indicated.
PROJECTED ACCRUAL: A maximum of 50 patients (25 HLA-matched related and 25 HLA-mismatched
related or matched unrelated) will be accrued for this study within 2 years (HLA-mismatched
related or matched unrelated donor stratum closed to accrual as of 1/11/06).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival
12 months post transplant
No
Hugo R. Castro-Malaspina, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
01-092
NCT00027560
July 2001
April 2009
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |